The Commercial Program Quality Oversight Manager role is a global role and reports to the Director, Quality Strategy and Governance within Amgen's R&D Quality, Compliance & Audit organization.

This role will be based at Amgen's Thousand Oaks site. Key Responsibilities:

Act as key interface with Commercial, Safety and other functions for all the Commercial Program Quality Oversight Team activities.

Apply a risk based approach to Patient Support Program (PSP) vendor monitoring / data reviews Interface with data privacy to determine acceptable records for review.

Gather information about the PSP and data availability to conduct an initial monitoring visit. Conduct monitoring visits to review records for safety reporting requirements (Ability to travel up to 25%).

Perform quarterly data reviews on the selected PSP programs.

Conduct quarterly quality evaluations of the PSP and Market Research repositories.

Review, revise and maintain business processes, process documentation/tools, and training for safety reporting requirements and vendor engagement of commercial programs.

Manage the R&D CAPA System (RDCS) items assigned to the Commercial Program Quality Oversight Team and act as the responsible person/BPO delegate to progress assigned exceptions through RDCS Present significant issues and proposed solutions to the Safety Compliance Committee

Maintain Sharepoint site / team repository.

Support activities to improve the R&D Quality Management System (QMS)

May represent Quality and the R&D QMS in Merger & Acquisition activities.